Actively Recruiting
Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma.
Led by University of Rostock · Updated on 2026-04-29
164
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic subdural hematoma (cSDH) is a very common disease, primarily affecting older people, and is associated with significant morbidity and mortality. The incidence described in the literature is approximately 5 per 100,000/year, but it occurs more frequently in the elderly, with up to 58 per 100,000/year. The recurrence rate is high and is described in the literature as 10 to 27%. Consequently, various studies have evaluated potential risk factors for hematoma recurrence, such as age, brain atrophy, mixed HU density in CCT, increased body mass index, and bilateral hematomas. The pathomechanism of recurrence is currently unknown. The mechanism of development after minor trauma and the progression of the hematoma to a symptomatic form remain unclear. A recent retrospective investigation submitted for publication by the applicant, regarding the occurrence of a low-grade infection in patients with recurrent hematomas, examined this as a possible cause. In this study, microbiological swabs were taken from the subdural space after hematoma evacuation. It was shown that a low-grade infection could be detected in approximately 30% of all hematoma recurrences. This is previously unknown in the neurosurgical literature. This raises the question of whether a low-grade infection is already present in the primary chronic subdural hematoma.
CONDITIONS
Official Title
Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be older than 18 years
- Require surgical treatment for chronic subdural hematoma
You will not qualify if you...
- Current or prior antibiotic treatment
- Presence of infection
- Recurrent chronic subdural hematoma
- Chronic subdural hematoma treated without surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UnIversity Medical Center Rostock
Rostock, Germany, 18057
Actively Recruiting
Research Team
D
Daniel PD Dr.med.habil. Dubinski, MD MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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